I have a hard time getting too excited about this...
Largest Ever MS Trial Completes Patient Enrollment
08-26-05 -- What's being described as the largest double-blind, randomized clinical trial for multiple sclerosis (MS) has completed its patient enrollment phase, according to the trial's sponsor, Berlin-based Schering AG. The trial will involve 2100 patients diagnosed with relapsing-remitting MS at more than 200 study centers located in 26 countries. It's aimed at testing the safety and effectiveness of a larger dose of Schering AG's Betaseron medication for the disease, and is called BEYOND, which stands for Betaferon® Efficacy Yielding Outcomes.
Are Larger Doses More Effective?
Betaseron has been available to MS patients in a 250 microgram dose for more than a decade. The FDA first approved it for relapsing MS in 1993. The medicine is a manmade form of interferon designed to treat relapsing-remitting MS by acting as an immune modulator. The drug is delivered as an injection subcutaneously every other day.
According to Schering AG, the drug can reduce the number of MS episodes by up to one-third, and can cut the number of moderate to severe symptom flare-ups in half.
In fact, this past April, the U.S. distributor of Betaseron, Berlex, released positive preliminary findings of a 16-year clinical trial that's testing the safety of the medication over a long period.1 The trial, which should be completed later this year, is expected to clear up questions about the effects of early treatment initiation on a patient's clinical disease course.
In the newest clinical trial, Schering AG wants to determine if patients will receive greater benefits from a 500 microgram (mcg) dose. It's not only twice the standard dose for this medication, but is also higher than that of any currently available interferon, Schering AG stated.
"The BEYOND study is expected to show that the BEYOND dose of Betaferon is more efficacious than any currently available interferon," said Joachim-Friedrich Kapp, MD, who heads the Specialized Therapeutics division at Schering AG, in a statement. "Our goal is to noticeably improve the outcome and prognosis of MS patients."
MS Medicines to be Compared
In the study, patients are being given injections of Betaseron every other day and investigators will then compare the outcome with that of glatiramer acetate (Copaxone), another medication available to treat MS manufactured by Teva Pharmaceutical Industries. It's the first head-to-head comparison of the two medications, Schering AG reported.
In an initial phase of the BEYOND trial published in late 2003,2 study investigators reported that both the standard 250 mcg dose and the double dose of 500 mcg were both safe and well tolerated. Additionally, magnetic resonance imaging (MRI) exams showed more patients taking the 500 mcg dose had better outcomes compared to the smaller dose. The average number of active lesions was reduced by about 90% with the 500 mcg dose compared to approximately 70% with the 250 mcg dose, the study found.
The final results of the study's latest phase are expected sometime in 2007, according to Schering AG.
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